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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC UNIVERSAL DRILL GUIDE, DRILL BIT INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC UNIVERSAL DRILL GUIDE, DRILL BIT INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-527
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
(b)(4) (rep hcp for): medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the drill guide was defective. (b)(6)(rep, for): no new information. Instrument is in possession of the site.
 
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Brand NameUNIVERSAL DRILL GUIDE, DRILL BIT
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key10057292
MDR Text Key190980117
Report Number1723170-2020-01430
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K974161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number960-527
Device Catalogue Number960-527
Device Lot Number171003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/03/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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